NCT00859339

Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC

A Phase II Trial of Neoadjuvant Cisplatin, Gemcitabine and Sunitinib Malate Followed by Radical Cystectomy for Transitional Cell Carcinoma (TCC) of the Bladder: Hoosier Oncology Group GU07-123

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Noah Hahn, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will investigate the activity of sunitinib combined with cisplatin and gemcitabine followed by radical cystectomy in patients with Transitional Cell Carcinoma (TCC) of the Bladder.

Detailed description

OUTLINE: This is a multi-center study. * Gemcitabine ( 1000 mg/m2) IV days 1 and 8 * Cisplatin (70 mg/m2) IV day 1 and * Sunitinib malate (37.5 mg) oral daily for days 1-14 The treatment regimen will be administered in four, 21-day, cycles followed by radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate. ECOG performance status 0 or 1 Hematopoietic: * Absolute Neutrophil Count (ANC) \> 1.5 K/mm3 \[(IS): 1.5 x 109/L\] * Platelets \> 100 K/mm3 \[(IS): 100 x 109/L\] * Hemoglobin (Hgb) \> 9.0 g/dL \[(IS): 90 g/L\] Hepatic: * Total bilirubin \< 1.5 x Upper Limit of Normal (ULN) * Aspartate aminotransferase (AST) ≤ 2.5 x ULN * Alanine aminotransferase (ALT) ≤ 2.5 x ULN Renal: * Calculated creatinine clearance of \> 60 cc/min Cardiovascular: * No uncontrolled angina, congestive heart failure or myocardial infarction or coronary/peripheral artery bypass graft within 6 months prior to registration for protocol therapy.

Conditions

• Transitional Cell Carcinoma of the Bladder

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine ( 1000 mg/m2) IV days 1 and 8
DRUG	Cisplatin	Cisplatin (70 mg/m2) IV day 1
DRUG	Sunitinib Malate	Sunitinib malate (37.5 mg) oral daily for days 1-14
PROCEDURE	Radical Cystectomy	Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-03-11
• Last updated: 2016-04-14
• Results posted: 2016-04-14

Locations

5 sites across 2 countries: United States, United Kingdom